Court of Justice 18-02-1997 ECLI:EU:C:1997:65

Opinion of Advocate General Lenz

delivered on 18 February 1997^(*)

1. In these Treaty infringement proceedings the Commission claims that the Kingdom of Belgium has failed to adopt the laws, regulations and administrative provisions needed to transpose Council Directive 93/42/EEC of 14 June 1993 concerning medical devices⁽¹⁾ into national law.

2. Under Article 22(1) of the directive, the Member States were required to adopt the laws, regulations and administrative provisions needed to comply with the directive by 1 July 1994 and to inform the Commission thereof forthwith.

3. The Kingdom of Belgium does not dispute that the directive has not been transposed into national law within the time-limit set. It merely states that the requisite legislation is being prepared.

4. I accordingly propose that the Court should declare that, by failing to adopt, within the prescribed time-limit, the measures needed to comply with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, the Kingdom of Belgium has failed to fulfil its obligations under the Treaty. I also propose that the Kingdom of Belgium should be ordered to pay the costs.